Medical products such as tube systems, catheters or intravenous sets are basically packed in sterile packages, sterilized within the latter and subsequently delivered. A sterile package on the one hand has to allow for sterilization and, on the other hand, has to ensure the sterility during appropriate storage until use of the medical products received therein. In general, re-contamination of the sterilized medical product after preparation thereof until use thereof has to be excluded. Medical single-use products such as blood tubes or surgical instruments are packed in bags or blister packs and are subsequently sterilized in a way known from prior art. The sterilization may be carried out in an individual package, in a dispenser box or stacked on a pallet. In the packages known from prior art the products are basically arranged loosely, i.e. not fixed within the (primary) package/a bag/a blister pack.
The loose arrangement of the medical products to be sterilized or having been sterilized in the package has the drawback, however, that during handling and transportation the packaged medical products are damaged or impaired especially by deformations, kinks or damage of the package. Moreover, the loose arrangement of the medical products in a bag may entail contamination, when plural loosely packed products such as blood tubes are removed, as at least portions of the products may get in contact with the ground during removal.
Furthermore, for example during electron beam sterilization (so called E-beam technology) the loose arrangement within the package results in an uneven distribution of the dose due to high scattered radiation which results in non-homogenous load of the medical products. The electron beam sterilization is based on penetration of the medical products to be sterilized including the package by highly energetic accelerated electrons which have an ionizing effect and thus are germ-killing. If in electron beam sterilization a required minimum radiation is gone below due to the scattered radiation, this results in non-sterility. On the other hand, over-radiation in the form of excessive energetic load of the medical products to be sterilized results in material changes such as discoloring, deterioration of the mechanical properties or ageing. Thus, the loose arrangement of the medical products to be sterilized does not allow, in the case of beam sterilization, minimized radiation of the individual medical product. Due to the high scattering occurring, an output of the beam source has to be high so as to ensure minimum radiation and thus sterility. An optional gas sterilization, on the other hand, produces high residual gas values and additionally requires a gas-permeable package.
Further drawbacks of prior art reside in the fact that the package after sterilization has to be further provided with a label for marking during an additional production step and that automated manufacture and, respectively, packaging of the medical products is possible to a limited extent only.